Trial Outcomes & Findings for (MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation (NCT NCT03412097)

Results Overview

An adverse advent is any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care.

Recruitment status

COMPLETED

Target enrollment

89 participants

Primary outcome timeframe

Up to 7 days post treatment - Day 0-7

Results posted on

2024-03-04

Participant Flow

Patients who agreed to participate in the study completed a pretreatment form. After treatment, patients were asked to complete a post-treatment form. Complete information was received on 89 patients (pretreatment and post-treatment forms).

Participant milestones

Participant milestones
Measure	Consecutive Patients Data from consecutive patients who sought care at Parker University's teaching clinic.
Overall Study STARTED	89
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Consecutive Patients n=89 Participants Patients who agreed to participate in the study (364 encounters) completed a pretreatment form. After treatment, patients were asked to complete a post-treatment form. Complete information was received on 89 unique patients (pretreatment and post-treatment forms) totaling 119 patient encounters.
Age, Continuous	39.5 years n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 days post treatment - Day 0-7

Population: 89 patients completed both the pre and post-treatment forms received. These were considered complete and thus used for study analysis.

An adverse advent is any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care.

Outcome measures

Outcome measures
Measure	Consecutive Patients n=89 Participants
Number of Patient Encounters That Report a New or Worsening Symptom	8 Participants

Adverse Events

All Consecutive Patients

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Consecutive Patients n=89 participants at risk Patients who agreed to participate in the study (consecutive) completed a pretreatment form. After treatment, patients were asked to complete a post-treatment form. Complete information was received on 89 patients (pretreatment and post-treatment forms).
Musculoskeletal and connective tissue disorders Worsening or new symptom	9.0% 8/89 • 0-7 days 1. All-Cause Mortality 2. Serious Adverse Events 3. Other (Not Including Serious) Adverse Events - This study's primary outcome definition for an adverse event is any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care.

Additional Information

Dr. Katherine A Pohlman

Parker University

Phone: 972 438 6932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place